
To capitalize on growing demand from international markets, St. Jude Medical (NYSE:STJ) is launching a new MR-Conditional pacemaker in India that will allow patients implanted with such a pacemaker to undergo a full-body MRI scan safely.
The Accent MRI pacemaker, among St. Jude’s roster of new innovative medical devices, is the first MR-Conditional pacemaker to allow a high-resolution, full-body scan without compromising the patient’s safety, said a St. Jude spokeswoman.
Scores of people implanted with pacemakers forego MRI scans because the magnetic resonance emerging as a result of the scan can disrupt the functioning of the pacemaker.
St. Jude’s Accent MRI has anew feature called “activator” that competing products don’t have, said Marisa Bluestone, the St. Jude spokeswoman.
“Unlike other MRI pacemakers, the St Jude pacemaker does not require a cardiologist or technologist from the pacemaker company to ‘program’ the pacemaker before the MRI scan,” Dr. Ulhas Pandurangi, chief electrophysiologist at Madras Medical Mission in Chennai, said in an email. “A radiologist who is always present at the MRI scan site may program the pacemaker safely by simply placing the ‘activator’ — a small device half the size of an iPhone — on the (patient’s) skin covering (the) pacemaker.”
Pandurangi added that the accompanying lead that St. Jude was launching in India is very user friendly given that no special skills are required by physicians to use them.
St. Jude Medical’s India manager Kaustav Bannerjee declined to disclose India revenue but implied that the demand for such a product would be strong since heart disease is on the rise in India.
“The World Health Organisation estimates that India is likely to emerge as the global capital of heart diseases by 2025,” Bannerjee said in an email. “However, at times patients have conditions in addition to heart disease and could benefit from an MRI scan at present or in the future. The Accent MRI is an important technology for those patients.”
MR-Conditional pacemakers have made the possibility of getting a MRI scan even with a pacemaker a reality. In the U.S., Medtronic is ahead of its competition in having not only an approved MR-Conditional pacemaker on the market — the Revo SureScan — but is currently testing a next-generation product.

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So is Inida the first country that this is approved in?
Was India chosen because of lower regulatory hurdles, much like the EU is chosen?
Does such a regulatory arbitrage enable fast commercialization of new technologies and does it give Indians and advantage over other citizens in other countries for leading edge treatments?
Comment by chris wasden — January 18, 2012 @ 11:21 am
No, the product was approved first in Europe. It is not yet available in the U.S. A St. Jude spokeswoman did not address whether regulatory hurdles led to the decision to launch it in India ahead of the U.S.
But there is a growing feeling – expressed in investor conferences and other events that I have attended – that regulatory hurdles in the U.S. are pushing device makers to launch outside the country. It used to be Europe and now they are going to Asia. In other words, U.S. patients may no longer be the first in line to enjoy innovations.
Comment by Arundhati Parmar — January 18, 2012 @ 2:36 pm
My father has a sudden cardiac arrest & he has a very high blood sugar (above 300) . Doctor suggested to use a St. Jude Pace Maker (DDR) for my Father ! It contains double chamber . The price of the Pace Maker is Rs. 125000 .
So , please say something about the Pace Maker ! Is it so needful for my father ? We live in Kolkata (West Bengal , INDIA) . Kindly say something .
Comment by Ritayan Mitra — January 22, 2012 @ 1:45 pm
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